This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety and performance of an investigational transcatheter aortic valve replacement system in patients with symptomatic severe native aortic valve stenosis who are considered appropriate candidates for transcatheter valve replacement. Eligible subjects will be enrolled at multiple investigational sites and followed according to the clinical investigation plan.
The study will assess procedural success, device performance, and clinical safety using predefined clinical and echocardiographic outcome measures. Subjects will undergo scheduled follow-up evaluations to assess device performance, functional status, quality of life, and the occurrence of adverse clinical events over the study period.
Age 60 years or older.
Symptomatic severe native calcific aortic valve stenosis.
Considered appropriate for transcatheter aortic valve replacement (TAVR) by the local Heart Team.
Considered at high surgical risk for surgical aortic valve replacement.
Contraindication to transcatheter aortic valve replacement or the investigational procedure.
Active infection or endocarditis.
Life expectancy less than one year due to non-cardiac comorbidities.
Participation in another investigational study that could interfere with the objectives of this study.